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U.S. Department of Health and Human Services

Product Classification

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Device instrumentation, surgical mesh, urogynecologic, transabdominal repair of pelvic organ prolapse
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Physical State needle passers and trocars, needle guides, fixation tools, and tissue anchors used with surgical mesh.
Technical Method Used with urogynecologic surgical mesh instrumentation to facilitate transabdominal pelvic organ prolapse repair procedures
Target Area vagina, uterus, sacrum, pelvic floor
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePWK
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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